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Cytokine Profiling Post-Heart Transplant

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ClinicalTrials.gov Identifier: NCT01643564
Recruitment Status : Terminated (Subject Recruitment)
First Posted : July 18, 2012
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft dysfunction.

Condition or disease
Cardiac Transplant

Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cytokine Profiling of Cardiac Transplant Recipients
Study Start Date : November 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1
Heart Transplant Recipients with Unexplained Graft Dysfunction
Group 2
Normal Control
Group 3
Class III-IV Heart Failure
Group 4
Heart Transplant Recipients with Normal Graft Function



Primary Outcome Measures :
  1. Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection [ Time Frame: 12 months ]
    Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cardiology Clinic and inpatient service. Normal controls are volunteers from within the community.
Criteria

Inclusion Criteria:

Group 1

  • 18 years and older
  • Cardiac Transplant recipient with graft dysfunction of unknown etiology

Group 2

  • 18 years or older
  • No history of heart failure or cardiac transplantation Group 3
  • 18 years or older
  • Class II-IV heart failure Group 4
  • 18 years or older
  • Heart Transplant 6 months or greater prior to blood draw
  • No graft dysfunction

Exclusion Criteria:

Group 1 Heart Transplant with Unexplained Graft Dysfunction

  • Cellular or antibody-mediated cardiac allograft dysfunction

Group 2 Normal Control group

  • Active infection within 1 month of blood draw
  • Known Inflammatory Disease

Group 3 Heart Failure Group

  • Active infection within 1 month of blood draw
  • Known Inflammatory Disease

Group 4 Heart Transplant with Normal Graft Function Group

  • Active infection within 1 month of blood draw
  • Known graft dysfunction
  • Known Inflammatory Disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643564


Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Peter M Eckman, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01643564     History of Changes
Other Study ID Numbers: 1111M06547
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Transplant
Cytokines
Graft Dysfunction